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Comparison of Intraoperative Best Practice Advisory Reminders to Protocolize Insulin Administration Versus Standard Care in Patients at High Risk of Hyperglycemia

Comparison of Intraoperative Best Practice Advisory Reminders to Protocolize Insulin Administration Versus Standard Care in Patients at High Risk of Hyperglycemia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05426096
Enrollment
7232
Registered
2022-06-21
Start date
2022-10-05
Completion date
2023-10-05
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hyperglycemia

Brief summary

This study will assess the implementation of a glucose management clinical decision support tool. The specific objective is to determine if supplementing the existing glucose check reminder with a best practice advisory (BPA), an actionable insulin dosing calculator, providers will be influenced to improve the control of hyperglycemia.

Detailed description

Poor intraoperative glucose control has been linked to multiple types of infections including surgical site infections and urinary tract infections. Several studies suggest maintaining glucose at less than 180 mg/dL effectively prevents infections, and minimizes risks of hypoglycemia as compared to stricter blood glucose targets. The insulin dosing protocol that will be used in the study is available for use throughout the Vanderbilt University Medical Center (VUMC) Department of Anesthesiology. The insulin calculator (BPA) automates the protocol guidelines. When a patient meets the study criteria, the BPA will provide an automated notification through the electronic health record system. These automated notifications will pop up intraoperatively after the glucose check reminder in cases where the patient meets the study criteria. The provider is not forced to follow the recommendations of the insulin dosing calculator, rather it just serves as a reminder of best practices as defined by our department. The specific objective is to determine if supplementing the existing glucose check reminder with a BPA, an actionable insulin dosing calculator, will influence providers to improve the control of hyperglycemia. Study results will guide the future integration of the BPA at VUMC.

Interventions

The BPA intervention will test the delivery of the insulin calculator (BPA) which automates the standard insulin dosing protocol guidelines through the electronic health record system.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The study will assess this intervention using a sequential and repeated cross-over design at the institutional level with periods of time for wash in, wash out, control and study intervention.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Patient Participants Inclusion Criteria: * All patients having surgery at Vanderbilt University Medical Center Main Operating Rooms (ORs), Vanderbilt Medical Center Children's Hospital, Medical Center East or Gynecological (4S) ORs, who qualify for the glucose check best practice advisory (BPA). To qualify for the glucose BPA, the patient must meet the following criteria: 1) a documented diagnosis of diabetes, without a recorded measurement of glucose within the last 2 hours, or 2) the patient had an insulin administration within the last twelve hours and did not have a recorded measurement of blood glucose within the last hour.

Exclusion criteria

* Patients having surgery at other locations * Patients not qualifying for the VUMC glucose check BPA Provider participants: Any provider of eligible patients may receive the BPA while providing care for these patients.

Design outcomes

Primary

MeasureTime frameDescription
Hyperglycemia (glucose >180 mmol/dL)PACU admission to discharge (1-3 hours post operatively)Frequency of hyperglycemia (glucose \>180 mg/dL) at first Post Anesthesia Care Unit (PACU) measurement.

Secondary

MeasureTime frameDescription
Adherence to Multicenter Perioperative Outcomes Group (MPOG) GLU-01IntraoperativeMPOG GLU-01 is a quality measure defined as the percentage of cases with perioperative glucose \>200 mg/DL with \>200 mg/dL with administration of insulin or glucose recheck within 90 minutes of original glucose measurement.
Intraoperative InsulinIntraoperativeTotal administered intraoperative insulin (Units)
Magnitude of intraoperative hyperglycemiaIntraoperativeMagnitude of intraoperative hyperglycemia defined as the product of time and glucose level when glucose is greater than 180 mmol/dL (the area outside of normoglycemia)
Glucose at first PACU measurementPACU admission to discharge (1-3 hours post operatively)Glucose at first PACU measurement
Hypoglycemia (glucose <60 mmol/dL)PACU admission to discharge (1-3 hours post operatively)Frequency of hypoglycemia (glucose \<60 mmol/dL) at first PACU measurement
Intraoperative glucose monitoringIntraoperativeFrequency of intraoperative glucose monitoring
Adherence to MPOG GLU-05IntraoperativePercentage of cases with administration of insulin within 90 minutes of blood glucose \>200 mg/dL.

Other

MeasureTime frameDescription
Incidence of surgical site infection30 days after surgeryIncidence of surgical site infection
Incidence of intraoperative hypokalemiaintraoperativeIncidence of intraoperative hypokalemia (mild: potassium \<3.5 mEq/L- 3.0 mEq/L; severe \<3.0 mEq/L)
Incidence of first postoperative hypokalemia3 hours post operativelyFirst postoperative hypokalemia (mild: potassium \<3.5 mEq/L- 3.0 mEq/L; severe \<3.0 mEq/L).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026